Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT04271592 | A Study to Assess Safety, Tolerability, and Pharmacokinetics of ABI-H3733 in Healthy Adults | PHASE1 | COMPLETED | 120 | — | — | May 17, 2020 | Jan 14, 2021 | Jan 27, 2021 | 1 | New Zealand |
| Arm | Type | Description |
|---|---|---|
| Part 1: SAD Cohorts 1-7 ABI-H3733 Liquid Form | EXPERIMENTAL | A single dose of ABI-H3733 liquid oral dosage form administered on Day 1. Cohort 1 will receive a 100-mg dose. Subsequent cohorts 2-7 will receive a ≤3-fold increase in dose from the previous cohort; the dose will be determined by evaluation of safety and PK data from previous cohorts. |
| Part 1: SAD Cohorts 1-7 Placebo Liquid Form | PLACEBO_COMPARATOR | A single dose of placebo matching ABI-H3733 liquid oral dosage form will be administered on Day 1. Cohort 1 will receive a 100-mg dose. Subsequent cohorts 2-7 will receive a ≤3-fold increase in dose from the previous cohort; the dose will be determined by evaluation of safety and PK data from previous cohorts. |
| Part 1: MAD Cohorts 8-10 ABI-H3733 Liquid Form | EXPERIMENTAL | Once-daily doses of ABI-H3733 liquid oral dosage form will be administered from Day 1 to Day 5. Cohort 8 will receive a dose determined from evaluation of the data from the SAD cohorts. Subsequent cohorts 9 and 10 will receive a ≤3-fold increase in dose from the previous cohort; the dose will be determined by evaluation of safety and PK data from previous cohorts. |
| Part 1: MAD Cohorts 8-10 Placebo Liquid Form | PLACEBO_COMPARATOR | Once-daily doses of placebo matching ABI-H3733 liquid oral dosage form will be administered from Day 1 to Day 5. Cohort 8 will receive a dose determined from evaluation of the data from the SAD cohorts. Subsequent cohorts 9 and 10 will receive a ≤3-fold increase in dose from the previous cohort; the dose will be determined by evaluation of safety and PK data from previous cohorts. |
| Part 2: Single Dose Fasted Cohort 11 ABI-H3733 Solid Form | EXPERIMENTAL | A single dose of ABI-H3733 solid oral dosage form will be administered in a fasted state on Day 1. The decision to proceed with Part 2 and the dose administered will be determined after evaluation of cumulative safety and PK data from Part 1. |
| Part 2: Single Dose Fasted Cohort 11 Placebo Solid Form | PLACEBO_COMPARATOR | A single dose of placebo matching ABI-H3733 liquid oral dosage form will be administered in a fasted state on Day 1. The decision to proceed with Part 2 and the dose administered will be determined after evaluation of cumulative safety and PK data from Part 1. |
| Part 2: Single Dose Fed Cohort 12 ABI-H3733 Solid Form | EXPERIMENTAL | A single dose of ABI-H3733 solid oral dosage form will be administered after a high-fat meal on Day 1. The decision to proceed with Part 2 and the dose administered will be determined after evaluation of cumulative safety and PK data from Part 1. |
| Part 2: Single Dose Fed Cohort 12 Placebo Solid Form | PLACEBO_COMPARATOR | A single dose of placebo matching ABI-H3733 solid oral dosage form will be administered after a high-fat meal on Day 1. The decision to proceed with Part 2 and the dose administered will be determined after evaluation of cumulative safety and PK data from Part 1. |
| Name | Type | Description |
|---|---|---|
| ABI-H3733 Liquid Oral Dosage Form | DRUG | ABI-H3733 liquid oral dosage form |
| ABI-H3733 Solid Oral Dosage Form | DRUG | ABI-H3733 solid oral dosage form |
| Placebo to ABI-H3733 Liquid Oral Dosage Form | DRUG | Placebo to ABI-H3733 liquid oral dosage form |
| Placebo to ABI-H3733 Solid Oral Dosage Form | DRUG | Placebo to ABI-H3733 solid oral dosage form |
Inclusion Criteria: * No clinically significant abnormal findings on physical exam, medical history, or clinical laboratory results at screening. Exclusion Criteria: * Positive test results for human immunodeficiency virus (HIV) or hepatitis B or C. * History of or current persistent drug or alco...